Clinical Trial: Intravenous Immunoglobulin Therapy in Optic Neuritis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief Summary:
To determine whether high-dose intravenous immunoglobulin (IVIg) is more effective than placebo in restoring lost visual function (visual acuity) in optic neuritis (ON).
To determine the time course of recovery following IVIg administration. If the reports of IVIg-associated clinical improvement occurring within 3 to 6 months following treatment can be confirmed, this would provide indirect evidence that IVIg may promote central nervous system (CNS) remyelination in optic neuritis and multiple sclerosis (MS).
Detailed Summary:
Optic neuritis is the leading cause of transient, spontaneous, reversible visual loss in young adults. Characteristically, patients present with central visual loss that peaks within a few days and is often associated with eye pain. Visual loss may be complete. Spontaneous recovery usually begins within 4 weeks, and marked recovery occurs within 1 to 3 months in most patients. Although clinical improvement is the rule, not all patients recover fully, and many are left with residual symptoms. Although there are limited pathological studies in inflammatory ON, the pathological changes are thought to be virtually identical with those seen in MS, with disruption of the blood-nerve (brain) barrier; primary demyelination with axonal sparing; variable degrees of lymphocytic infiltration; an abundance of macrophages around the inflammatory demyelination lesion; various degrees of remyelination; and, later, oligodendrocyte loss, axonal loss, and gliosis.
Remyelination by oligodendrocytes occurs early in the MS lesion, as documented by myelin sheaths that are abnormally thin relative to axon diameter. These thin myelin sheaths are often seen prominently at the edge of demyelinated plaques. A recent series of studies has shown that within weeks of the initial event, there is extensive oligodendrocyte regeneration and remyelination. These immature oligodendrocytes express a series of developmentally restricted antigens. This finding has been interpreted to suggest that the cells that repopulate the acute plaque and that affect remyelination are newly generated and not residual, mature oligodendrocytes. These observations support the possibility that factors that promote remyelination could be used to improve clinical recovery in ON and MS.
Work at the Mayo Clinic, has shown that both immunoglobulin G (IgG) directed against spinal cord
Sponsor: National Eye Institute (NEI)
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Eye Institute (NEI)
Dates:
Date Received: September 23, 1999
Date Started: August 1995
Date Completion:
Last Updated: September 16, 2009
Last Verified: September 2009
